The new topical ascomycin derivative SDZ ASM 981 does not induce skin atrophy when applied to normal skin for 4 weeks: a randomized, double-blind controlled study

Queille‐Roussel, C.; Paul, C.; Duteil, L.; Lefebvre, Maxime; Rapatz, G.; Zagula, M; Ortonne, Jean‐Paul

doi:10.1046/j.1365-2133.2001.04076.x

Cited by 201 publications

(154 citation statements)

References 20 publications

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“…13,14 As a nonsteroid, pimecrolimus does not induce skin atrophy. 15 Pharmacokinetic studies in adults and pediatric patients with extensive AD lesions have shown negligible absorption of pimecrolimus through the skin, greatly reducing the likelihood of systemic effects after topical application, even in infants with extensive skin lesions. 16 In this study, we evaluated whether early treatment of AD signs and symptoms with pimecrolimus would influence long-term disease outcome by preventing progression to AD flares.…”

mentioning

confidence: 99%

Efficacy and Safety of Pimecrolimus Cream in the Long-Term Management of Atopic Dermatitis in Children

Wahn

Bos

Goodfield³

et al. 2002

Pediatrics

331

348

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ABSTRACT. Objective. Pimecrolimus cream (SDZ ASM 981), a nonsteroid inhibitor of inflammatory cytokines, is effective in atopic dermatitis (AD).We assessed whether early treatment of AD signs/symptoms with pimecrolimus could influence long-term outcome by preventing disease flares.Methods. Early intervention with pimecrolimus was compared with a conventional AD treatment strategy (ie, emollients and topical corticosteroids). In this 1-year, controlled, double-blind study, 713 AD patients (2-17 years) were randomized 2:1 to a pimecrolimus-based or conventional regimen. Both groups used emollients for dry skin. Early AD signs/symptoms were treated with pimecrolimus cream or, in the conventional treatment group, vehicle to prevent progression to flares. If flares occurred, moderately potent topical corticosteroids were mandated. The primary efficacy endpoint was ranked flares at 6 months. Safety was monitored clinically, and a skin recall-antigen test was performed at study completion.Results. Baseline Characteristics of the Patients. The mean age for both groups was approximately 8 years, and the majority of patients had moderate disease at baseline.Patient Follow-up and Exposure to Study Medication. The mean duration of follow-up (؎standard error) was 303.7 (؎5.30) days in the pimecrolimus group and 235.2 (؎9.40) days in the control group. The discontinuation rate was significantly higher in the control group than in the pimecrolimus group (51.5% vs 31.6% at 12 months), and proportionately more patients with severe or very severe disease discontinued in the control group. The main reason for the higher discontinuation rate in the control group was unsatisfactory therapeutic effect (30.4% vs 12.4%). This resulted in a substantially higher mean number of study medication treatment days in the pimecrolimus group compared with the control group: 211.9 (69.8% of study days) versus 156.0 (66.3% of study days). Of those patients who completed 12 months on study, 14.2% and 7.0% of patients in the pimecrolimus and vehicle groups, respectively, used study medication continuously.Efficacy. Patients in the pimecrolimus group experienced significantly fewer AD flares than those in the control group, according to the primary efficacy analysis on ranked flares of AD (Van Elteren test). The proportion of patients who completed 6 or 12 months with no flares was approximately twice as high in the pimecrolimus group compared with control (61.0% vs 34.2% at 6 months; 50.8% vs 28.3% at 12 months). Fewer flares were observed in the pimecrolimus group regardless of baseline disease severity, so even severe patients derived benefit from the treatment. The analysis of time to first flare showed that treatment with pimecrolimus was associated with a significantly longer flare-free period (logrank test). Covariate analysis indicated a statistically significant effect on time to first flare of baseline Eczema Area and Severity Index score, and whether patients had "severe" or "very severe" disease at baseline according to the Investigators'...

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confidence: 99%

Efficacy and Safety of Pimecrolimus Cream in the Long-Term Management of Atopic Dermatitis in Children

Wahn

Bos

Goodfield³

et al. 2002

Pediatrics

331

348

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“…26,27 Unlike TCSs, it does not cause skin atrophy and does not affect the hypothalamic-pituitary-adrenal axis. 26,28 Pimecrolimus cream was developed specifically for the treatment of inflammatory skin diseases, such as AD, allergic contact dermatitis, and chronic irritant hand dermatitis. [29][30][31][32][33][34] The development program for AD involved a large number of infants (defined as subjects Ͻ24 months of age) and children, in recognition of the fact that AD is primarily a pediatric disease.…”

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confidence: 99%

Safety and Tolerability of 1% Pimecrolimus Cream Among Infants: Experience With 1133 Patients Treated for Up to 2 Years

et al. 2006

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Pimecrolimus is a calcineurin inhibitor developed for the topical treatment of atopic dermatitis. During the clinical development of 1% pimecrolimus cream, 1133 patients 3 to 23 months of age with mild to severe atopic dermatitis were treated for up to 2 years. The objective of this review is to discuss the safety and tolerability of 1% pimecrolimus cream among infants, on the basis of the combined results from all studies (4 pharmacokinetic studies and 6 clinical trials) conducted among these patients. Pimecrolimus blood concentrations measured for 35 patients were consistently low (Յ1 ng/mL in Ͼ80% of samples), irrespective of the disease severity and extent, and remained low during intermittent treatment for up to 1 year. The level of systemic exposure to pimecrolimus among infants was comparable to that observed for older pediatric patients enrolled in the same studies and treated in the same way with 1% pimecrolimus cream, which indicated that young pediatric patients are not at higher risk of significant percutaneous absorption of topically applied pimecrolimus, despite their large skin surface area/body mass ratio. The 6 clinical trials included a total of 1098 infants, who were treated for periods ranging from 4 weeks to 2 years. Most of these patients (60%) had moderate to severe disease at baseline. The most frequently reported adverse events were common childhood disorders such as nasopharyngitis, pyrexia, upper respiratory tract infections, ear infections, and bronchitis. During the double-blind (DB) studies or DB phases of studies, the incidence rates for the most frequently reported adverse events were similar for patients who received 1% pimecrolimus cream and patients who received the vehicle, except for the incidence of teething, which was higher among the pimecrolimus-treated infants (relative risk: 2.02; 95% confidence interval: 1.32-3.27). Treatment with 1% pimecrolimus cream was not associated with an increase in the overall incidence of nonskin infections, compared with the vehicle (relative risk: 1.015; 95% confidence interval: 0.88 -1.18). The incidence density (ID) rates for total bacterial, fungal, parasitic, and viral skin infections during the DB studies or DB phases of www.pediatrics.org/cgi

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“…The main reason for developing new drugs as an alternative to topical steroids is to overcome side-effects, such as thinning of the skin and adrenal gland suppression, and recent studies have demonstrated that skin thinning is avoided with the use of pimecrolimus cream 19 . This pilot study demonstrates that pimecrolimus 1% cream as monotherapy was effective in the amelioration of the skin score of patients of DLE, before treatment was 6.78 ± 1.36 and after treatment was 3.97 ± 1.21 (P = 0.001).…”

Section: Discussionmentioning

confidence: 99%

“…Patients were scheduled for follow-up visits at 2-week intervals. Clinical severity score was determined by assessing three factors including erythema, infiltration and presence of scale (0 = normal; 1 = mild; 2 = moderate; 3 = severe) 2,16,19 . Therefore, by adding the scores given to these three independent criteria, the minimum and maximum clinical scores were 0 (normal skin) and 9 (maximum skin damage), respectively, with mild, moderate and severe disease severity defined as scores of 1-3, 4-6 and 7-9, respectively.…”

Section: Methodsmentioning

confidence: 99%

Efficacy and Safety of Pimecrolimus Cream (1%) in the Treatment of Discoid Lupus Erythematosus

Husain¹,

Rahim

Alam³

et al. 2018

Med. Today

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The new topical ascomycin derivative SDZ ASM 981 does not induce skin atrophy when applied to normal skin for 4 weeks: a randomized, double-blind controlled study

Cited by 201 publications

References 20 publications

Efficacy and Safety of Pimecrolimus Cream in the Long-Term Management of Atopic Dermatitis in Children

Efficacy and Safety of Pimecrolimus Cream in the Long-Term Management of Atopic Dermatitis in Children

Safety and Tolerability of 1% Pimecrolimus Cream Among Infants: Experience With 1133 Patients Treated for Up to 2 Years

Efficacy and Safety of Pimecrolimus Cream (1%) in the Treatment of Discoid Lupus Erythematosus

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